Ultraverse® 035 PTA Dilatation Catheter U3575106Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741094590), received between Jan 16, 2020 and Apr 28, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2022Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AND DETACHED. IT WAS FURTHER REPORTED THAT THE DEVICE SEGMENTS ARE REMOVED USING VENOTOMY. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14236036 ↗
• InjuryMar 24, 2022Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY IN A LEFT UPPER ARM FISTULAGRAM, THE BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT MID BALLOON SHAFT WAS ALLEGEDLY BROKEN AND DISTAL HALF OF THE BALLOON WAS STILL IN PATIENT. REPORTEDLY VEINOTOMY WITH ADDITIONAL ACCESS SITE WAS USED TO RETRIEVE THE BALLOON SEGMENTS. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. PATIENT REPORTED AS STABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13892688 ↗
• MalfunctionSep 27, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE CATHETER OF THE DEVICE WAS ALLEGEDLY FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12531241 ↗
• MalfunctionJan 16, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. THE INFORMATION REVIEWED INDICATED THAT MODEL U3575106 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9596971 ↗